FDA Adverse Event
Other
Summary report: N
60 DEG. MICRO ABLATOR-S PROBE W/ SUCTION
MDR report key: 679127
·
Received February 23, 2006
Report
- Report Number
- 1216828-2006-00010
- Event Type
- Other
- Date Received
- February 23, 2006
- Date of Event
- February 1, 2006
- Report Date
- February 22, 2006
- Manufacturer
- SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION
- Product Code
- HXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS UNDERGOING A WRIST ARTHROSCOPY PROCEDURE. WHEN THE DOCTOR HAD COMPLETED THE PROCEDURE, HE NOTICED AN APPROXIMATELY 4MM CIRCULAR BURN-THROUGH IN THE SKIN ON THE BACK OF THE WRIST. THE DOCTOR CUT OUT THE BURNED PORTION AND SUTURED THE SKIN BACK TOGETHER. THEY BELIEVE THE BURN WAS NOT CAUSED BY CONTACT OF THE ABLATOR PROBE WITH THE LINVATEC TRACTION TOWER BECAUSE THE BURN WOULD HAVE BEEN SQUARE AND NOT ROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 60 DEG. MICRO ABLATOR-S PROBE W/ SUCTION | ABLATION PROBE, MONOPOLAR | HXB | SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION | 7209641 | 50140217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |